The Effect of Neuromuscular Stimulation on Post-Transplant Leg Edema

Lawson Health Research Institute

Status: Completed

Conditions: Edema; Kidney Transplant; Kidney Pancreas Transplant

Treatments: Device: Geko device

Study type: Interventional

Funder types: Other

Identifiers

NCT01860820

103618

Details and patient eligibility

About

This will be a randomized, controlled trial involving kidney and kidney pancreas transplant patients. There will be 2 groups and patients that will be randomized to one of the two groups. Clinical outcomes will be compared for those in each group and clinical differences between patients who receive routine medical therapy with IPC/TEDS versus the Geko device will also be evaluated.

Full description

This will be a randomized, controlled trial involving kidney and kidney pancreas transplant patients. There will be 2 groups and patients will be randomized to one of the two; one will receive standard of care IPC or TED stockings to help with circulation, the other group will use the geko device which is a newer device with Health Canada approval. Clinical outcomes will be compared for those in each group and clinical differences between patients who receive routine medical therapy with IPC/TEDS versus the Geko device will also be evaluated.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female
• At least 18 years old
• Undergoing kidney or kidney pancreas transplant surgery as the recipient
• Able and willing to provide written informed consent
• Absence of known peripheral vascular disease
• Body Mass Index of between 18 and 34
• Leg circumference at site of geko™ device placement is 24" or less

Exclusion criteria

• History of deep vein thrombosis
• Temporary or permanent cardiac pacing
• Patient is pregnant
• Any patient which may be excluded by way of warnings in the Manufacturer's Instructions for Use
• Any patient who requires an ECG electrode applied on the leg for continuous monitoring throughout therapy
• Previous leg(s) amputation
• Presence of any of the following in the site of intended device placement: cancerous lesion, swollen or infected or inflamed areas or skin eruptions i.e. phlebitis, thrombophlebitis, varicose veins
• History or signs of haematological disorders (especially in relation to clotting or coagulation disorders) including presence or history of thrombus formation
• BMI index >36
• Patients with any neurological disorder or disease that would interfere with proper assessment and or conduct of the trial
• History of implantable brain or other stimulator
• Patients who can not tolerate the stimulation from the GEKO device

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Best Medical Therapy

No Intervention group

Description:

Participants will follow standard post-transplant protocols with IPC

Geko device

Active Comparator group

Description:

Participants will be fitted with the device to ensure that it functions according to the manufacturer's instructions by a trained technician. This device will be changed every 24 hours. The device is worn on both legs and is worn for 24 hours a day. The device will first be put on the first day following the day of surgery and will then be changed the following day at the same time for a total of 7 days after surgery.

Treatment:

Device: Geko device